BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902319 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00077
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    July 16, 2012
    Report Date
    February 16, 2014
    Manufacturer
    AMERICAN OPTISURGICAL, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SERVICE RECORD, AND WITHOUT EVALUATING THE UNIT, THE CAUSE FOR MALFUNCTION CANNOT BE DETERMINED. ON 08/06/2012: AS OF THIS DATE, THERE ARE (B)(4) DOCUMENTED DEVICE COMPLAINTS COVERING (B)(4) UNITS. THIS LOT HAS (B)(4) RELEASED UNITS. THE COMPLAINT RATE IS AT (B)(4). THE LOT WILL CONTINUE TO BE MONITORED. NO CAPA WILL BE ISSUED SINCE THE COMPLAINT RATE IS BELOW (B)(4) AND THE INCIDENCES CAN BE CONSIDERED OPERATOR INEXPERIENCE. ON 02/04/2014: OPENED CAPA (B)(4) TO REVIEW 2012 COMPLAINTS. UPDATED WITH THE FOLLOWING DETAILS: THE UNIT HAD MADE PT CONTACT AND WAS NOT RECEIVED FOR EVAL. IT IS NOT POSSIBLE TO DETERMINE AN ASSIGNABLE CAUSE FOR THIS ISSUE. THERE IS INSUFFICIENT INFO FOR A COMPETE INVESTIGATION. RGA (B)(4) WAS FOR UNOPENED DEVICES. COMPLETED AND ATTACHED A CURRENT MDR DECISION FLOWCHART. THE DHR FOR LOT # 12912-04 WAS REVIEWED. THE UNIT MET MFG SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. THIS LOT HAS A (B)(4) COMPLAINT RATE. THERE WERE (B)(4) UNITS RELEASED TO DISTRIBUTION. A REVIEW OF LOT HISTORY SHOWED THAT THERE WERE A TOTAL OF (B)(4) UNITS THAT STOPPED WORKING. A REVIEW OF THE CONSOLE HISTORY WAS NOT PERFORMED BECAUSE THE CONSOLE SERIAL NUMBER WAS NOT REPORTED WITH THE COMPLAINT.

    Description of Event or Problem · 1

    CONSOLE AND/OR HANDPIECE WOULD NOT PROPERLY FUNCTION DURING CASE. THE CONSOLE KEPT SAYING CHECK HAND PIECE. THEN AFTER THE FIRST HANDPIECE DIDN'T WORK WE OPENED THE OTHER TWO. BOTH OF THOSE EITHER SAID CHECK HANDPIECE OR WATER FLOW BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113504 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL AMERICAN OPTISURGICAL, INC. 12912-04

    Patients

    Seq Age Sex Outcome Treatment
    1